FDA 483 - Eli Lilly and Company - November 26, 2024

An FDA inspection of Eli Lilly and Company in Concord, NC, revealed an issue with equipment design related to drug product storage. Specifically, the firm's temperature mapping verification for semi-finished syringes was found to be inadequate because the load pattern simulation did not accurately represent a full load. This indicates a deficiency in ensuring appropriate storage conditions for drug products.